Does the FDA keep us safe?

Research into new medications is how we learn if they work and if they’re safe.  It’s the only protection we have against snake oil and worse.  But disasters like Thalidomide and Vioxx – not to mention the dozens of products recalled monthly – remind us that the FDA screws up every now and then.

That’s because drug companies often pretty much lie to get their drugs approved.  Here’s how.

1) Report results that didn’t happen

Amazingly enough, some drug companies take studies that show their product doesn’t work, and they report that it does!  This has happened at least 11 times with studies into antidepressants.

Another form of this is to write a conclusion that’s different from what the actual results show.  Because of time pressure, doctors don’t have time to actually read all the papers thrown at them, and often just read the abstract, which contains the pro-drug message like:  “Conclusion:  Fake drug has been shown to be safe and efficacious in treating extreme bladder discomfort.”

2) Use faulty statistics

There’s a reason Benjamin Disraeli said “there are lies, damn lies, and statistics.”  The sheer amount of ways to manipulate the data from studies by statistics is mind-boggling.  The simplest is to report that something is statistically significant when that doesn’t mean anything.

For instance, a drug can have a statistically significant effect on blood pressure – but that effect is tiny and meaningless.

3) Use inappropriate measuring systems

Some things are easy to measure, like someone’s height or weight.  Others, like mental states and attitudes, are a lot harder.  Psychological assessments range from solid to extremely shaky, like the infamous Rorschach blotch test.

Thank God no drug has been approved because of results of a Rorschach blotch test.  But drug companies always use the measuring system that puts their drug in the best light, even if it doesn’t mean it actually works.

4) Don’t use placebo

When you don’t test your treatment against placebo, absurd things happen.  Like the gastric freezing procedure to treat ulcers, which consists of putting a balloon full of frozen liquid into the stomach to cool it off.  It worked great – until it was tested against a placebo, or a fake treatment.

Guess what?  The placebo worked better.

5) Don’t test against other drugs

You’d have to be crazy to forget about testing against a placebo.  But what drug companies almost never do is test their drugs against other drugs that already exist.

Vyvanse, for instance, is a new medication for ADHD that is chemically identical to Dexedrine.  It’s a hell of a lot more expensive, so there’s no way that it’s ever going to be tested if it’s actually better to the treatment that already existed.

6) Ignore the FDA

This is by the far the stupidest thing a drug company can do.  You’d have to be crazy to ignore what the FDA tells you to do in testing your medication.  But that’s exactly what Sam Waksal did with the breakthrough cancer drug Erbitux.

They told him to conduct certain studies and change some of his protocols.  He didn’t.  The worst part is, Erbitux was a drug that could help treat cancer in some of the worst cases.  Then Sam was surprised when his drug was rejected!

7) Pressure patients to give the results you want

If you give patients a test at the start of the trial, like a mood inventory scale, and then again at the end of the trial, they won’t answer the same.  Their past experience biases how they respond the second time around.

Also, you can subtly pressure participants to give results you want by leading questions.

8)  Test it for short periods of time

Take a drug that needs to be taken for months if not years, like an anti-depressant.  Why not just test it for a few weeks?  Not only will you save money, you won’t have to learn about the nasty side effects caused by long term use.

Everyone wins, except the patients.

9) Test it on a few people

Who cares if your drug will be taken by millions?  Test it on only several hundred people.  That makes it even easier for you to run the test again if you are so unlucky as to get bad results.

10) Test it on people who’re different

Test your drug on people who are healthier than those who will eventually take it.  You’re almost guaranteed better results.

Prozac, for instance, while now used for dozens of reasons including pain management, was initially tested on mild-to-moderately depressed people – not people who were extremely depressed.  Stuff like that explains why antidepressants don’t work nearly as well as they’re supposed to.

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Do you trust the drug companies?  Why or why not?